nashik site

Megafine has two US FDA inspected multipurpose cGMP API and Advanced Intermediate manufacturing facilities at Nashik, Maharashtra and Vapi, Gujarat in India. Besides the Nashik facility is also inspected by European EMEA, Korean FDA & approved by Japanese PMDA.

Nashik manufacturing site is located about 210 km northeast of Mumbai on the State Highway No. 17, in Lakhmapur, Dindori, Nashik, Maharashtra, India (Place/Taluka/District/State/Country). The distance to the plant from Nashik city is 30 km.

The site is situated on a private industrial area spread across 8.07 acres of land. The total area of the site is 32,667.00 sq. meters with an existing built up area of 17390.20 sq. meters.

The site has a total of five multipurpose API Production Blocks with dedicated manufacturing streams in each block. The blocks have been designed in a way that a single batch size as low as 2 kg & going up to 500 kg can be taken under cGMP environment.

The production blocks have multiple streams designed for the manufacturing and packaging of Active Pharmaceutical Ingredients (APIs) and Intermediates. Production Blocks are connected to the Clean Rooms which consist of Wet Milling, Drying (Fluid Bed Dryer [FBD], Tray Dryer [TD]), Rotary Cone Vacuum Drier (RCVD), Agitated Nutsche Filter Dryer(ANFD) Milling, Blending, Packing, Quarantine and Finished Good Storage areas. Its design meets the clean room ISO 8 class 100,000 standards and positive pressures are maintained as required. The air supplied is filtered through 10µm, 3µm and 0.3µm filters (HEPA) with minimum 30 air changes/hr. Micronizing facility is available at the site for particle sizing.

An intermediate production block for large volume products is available under cGMP environment. . The site has a centralized Quality Control Laboratory which is equipped with modern testing instruments and equipments. The Quality Control Lab is also supported with a well- equipped microbiological laboratory.

The site has a well-planned utility system which ensures regular supply of steam, electricity, filtered air, chilled water and purified water. The entire system is orderly placed to avoid cross contamination and mix-ups, and to meet the regulatory requirements.

The equipment installed allows a wide range of process variables in operation conforming to Current Good Manufacturing Practice (cGMP) requirements.

The Nashik site is successfully inspected by US-FDA, European EMA, Korean FDA,WHO & approved by Japanese PMDA.The site is also certified for, ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007.

The site has the following Accreditations -

Authority

Abbreviation

Country

Certification

Food and Drug Administration, USA

USFDA

USA

USFDA

European Medicines Agency

EMA

Slovenia

JAZMP

Pharmaceutical and Medical Devices Agency

PDMA

Japan

AG12300130

Korean Food and Drug Administration

KFDA

Korea

KFDA

Food and Drug Administration, Maharashtra State

FDA

India

GMP

Ministry of Health, Iran

MoH

Iran

MoH

World Health Organization

WHO

International

GMP

Written Confirmation for EU

CDSCO

India

EU WC

Occupation Health and Safety Assessment Series

OHSAS

India

OHSAS 18001:2007

International Organization for Standardization

ISO

India

ISO 14001:2004

International Organization for Standardization

ISO

India

ISO 9001:2008

Dun & Bradstreet Corporation (Nashik Site)

D&B D-U-N-S

USA

92-562-7080

vapi site

Megafine has two US FDA inspected multipurpose cGMP API and Advanced Intermediate manufacturing facilities at Nashik, Maharashtra and Vapi, Gujarat in India. Besides the Nashik facility is also inspected by European EMEA, Korean FDA & approved by Japanese PMDA.

Vapi manufacturing site is located at a large industrial township in GIDC (Gujarat Industrial Development Corporation), Vapi, Gujarat, India (City/State/Country) which is about 186 km North of Mumbai city on the national highway NH-8. The distance of the plant from Vapi railway station/town is around 5 km.

The site specializes in developing and manufacturing advance intermediates (KSM) with full regulatory support for our customers. All processes related to manufacturing of various drug intermediates involving chemical synthesis, isolation, purification, drying, milling, blending and packing, in process controls and testing by the quality control laboratory, etc. are carried out at this site.

The site has three manufacturing blocks, apart from Quality Control Laboratory, Raw Material Stores, Finished Goods Stores, Utility Section, Boiler Room and Effluent Treatment Plant (ETP). The production blocks have multiple streams designed for the manufacturing and packaging of Advanced Intermediates. Production Blocks are connected to the Clean Room which consists of Wet Milling, Drying (Fluid Bed Dryer [FBD], Tray Dryer [TD]), Milling, Blending, Packing, Quarantine and Finished Good Storage areas. The area is controlled under forced ventilation (VUS & VUE) with proper air filtration of 20µm, 10µm and 3µm with minimum 30 air changes/hr.